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A Study of Durvalumab Alone and Durvalumab+Olaparib in Advanced, Platinum-Ineligible Bladder Cancer (BAYOU)

NCT03459846 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 154

Last updated 2026-05-11

Study results available
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Summary

A Phase II, Randomized, Multi-Center, Double-Blind, Comparative Global Study to Determine the Efficacy and Safety of Durvalumab in Combination With Olaparib for First-Line Treatment in Platinum-Ineligible Patients With Unresectable Stage IV Urothelial Cancer

Conditions

  • Urinary Bladder Neoplasms

Interventions

DRUG

Durvalumab

Durvalumab 1500 mg IV q4w

DRUG

Olaparib

Olaparib PO 300 mg BID adjusted based on patient's creatinine clearance.

DRUG

Placebo

Matching placebo for oral tablet BID

Sponsors & Collaborators

Principal Investigators

  • Jonathan Rosenberg, MD · Memorial Sloan Kettering Cancer Center

  • Mark Lanasa, MD · One MedImmune Way,Gaithersburg,Maryland,United States

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-16
Primary Completion
2020-10-15
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Russia
  • South Korea
  • Spain
  • Taiwan
  • Vietnam

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03459846 on ClinicalTrials.gov